Regulatory Affairs Associate

Job Title: Regulatory Affairs Associate

Duration: 12 Months (Potential Extension)

Location: Hybrid in Lake County, IL 60045

Experience Level: 3-5 Years

Job Responsibilities:

• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing changes for Class III implantable medical devices.

• CMC (Chemistry, Manufacturing, Controls) background in completing clinical submissions.
• IND/IMPD submission background based on manufacturing batch records.
• Early Phase CMC knowledge is a plus.
• French/English speaking is a plus.

• May require an advanced degree and 3 to 5 years of direct experience in the field.
• Recent experience with Class III implantable medical devices.
• Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements.
• Knowledge of FDA PMA guidance documents and CFR regulations.
• Relies on extensive experience and judgment to plan and accomplish goals.
• Performs a variety of tasks.
• May lead and direct the work of others.
• A wide degree of creativity and latitude is expected.

1. Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies.
2. Technical writing skills.
3. Familiar with typical manufacturing processes, especially cell cultures.
4. Familiar with microbial methodology.
5. Familiar with ICH and country regulatory procedures for clinical trials.
6. Able to work with electronic systems, i.e., Microsoft and dossier publication systems.